CPhT Pharmacy Law 3 — Questions and Answers
Question 1: A pharmacy technician notices a prescription lacks the prescriber's DEA number for a Schedule II drug. What is the correct action?
- Ask the pharmacist to verify and obtain the DEA number before dispensing (Correct answer)
- Fill the prescription and note the missing DEA number in the log
- Refuse the prescription without consulting the pharmacist
- Dispense the medication and request the DEA number later
Correct answer: Ask the pharmacist to verify and obtain the DEA number before dispensing
A missing DEA number on a controlled substance prescription is a legal deficiency; the pharmacist must verify and obtain this information before dispensing.
Question 2: Which law prohibits re-importation of prescription drugs into the US except under specific FDA-approved circumstances?
- Prescription Drug Marketing Act (PDMA) (Correct answer)
- Drug Price Competition Act
- Federal Food Drug and Cosmetic Act
- Safe Medical Devices Act
Correct answer: Prescription Drug Marketing Act (PDMA)
The PDMA of 1987 restricts re-importation of US-manufactured drugs, with limited exceptions for manufacturers and FDA-authorized cases.
Question 3: Under HIPAA, which of the following is considered protected health information (PHI)?
- Patient name combined with diagnosis (Correct answer)
- De-identified statistical health data
- Aggregate prescription trend reports
- Anonymous patient survey responses
Correct answer: Patient name combined with diagnosis
PHI is any individually identifiable health information, including a patient name combined with medical or prescription information.
Question 4: How long must a pharmacy retain records for Schedule II controlled substances under federal law?
- 2 years (Correct answer)
- 1 year
- 5 years
- 7 years
Correct answer: 2 years
Federal DEA regulations require pharmacies to retain Schedule II controlled substance records for a minimum of 2 years.
Question 5: Which DEA form is used to report the theft or significant loss of controlled substances?
- DEA Form 106 (Correct answer)
- DEA Form 222
- DEA Form 41
- DEA Form 363
Correct answer: DEA Form 106
DEA Form 106 (Report of Theft or Significant Loss of Controlled Substances) must be submitted to the DEA when controlled substances are stolen or significantly lost.
Question 6: What is the maximum valid period for a Schedule II prescription in most states?
- 6 months from the date written (Correct answer)
- 1 year from the date written
- 30 days from the date written
- 90 days from the date written
Correct answer: 6 months from the date written
Federal regulations allow Schedule II prescriptions to be filled up to 6 months from the written date, though individual states may impose shorter limits.
Question 7: Which provision of the Affordable Care Act (ACA) required insurance plans to cover contraceptives without cost-sharing?
- Preventive services mandate (Correct answer)
- Essential health benefits requirement
- Individual mandate provision
- Medicaid expansion clause
Correct answer: Preventive services mandate
The ACA's preventive services mandate required most health plans to cover FDA-approved contraceptives and other preventive services at no cost to the patient.
CPhT Pharmacy Law 3
A pharmacy technician notices a prescription lacks the prescriber's DEA number for a Schedule II drug.
What is the correct action?